Brand Name(s):

• Afrin®Nasal Spray
• Anefrin®Nasal Spray
• Dristan®Nasal Spray
• Mucinex®Nasal Spray
• Nostrilla®Nasal Spray
• Vicks Sinex®Nasal Spray
• Zicam®Nasal Spray

IMPORTANT WARNING:

[Posted 10/25/2012]ISSUE:FDA is warning healthcare professionals and the public that accidental ingestion by children of over-the-counter eye drops used to relieve redness and nasal decongestant sprays can result in serious and life-threatening adverse events. The eye drops and nasal sprays that have been involved in the cases of accidental ingestion contain the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline. The cases of accidental ingestion reviewed by FDA occurred in children 5 years of age and younger. No deaths were reported; however, serious events requiring hospitalization such as nausea, vomiting, lethargy, tachycardia, decreased respiration, bradycardia, hypotension, hypertension, sedation, somnolence, mydriasis, stupor, hypothermia, drooling, and coma have occurred. Ingestion of only a small amount (1-2 mL; for reference, there are 5 mL in a teaspoon) of the eye drops or nasal spray can lead to serious adverse events in young children.

WHY is this medicine prescribed?

Oxymetazoline nasal spray is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Oxymetazoline nasal spray should not be used to treat children younger than 6 years of age unless it is recommended by a doctor. Children 6 to 12 years of age should use oxymetazoline nasal spray carefully and under adult supervision. Oxymetazoline is in a class of medications called nasal decongestants. It works by narrowing the blood vessels in the nasal passages.

HOW should this medicine be used?

Oxymetazoline comes as a solution (liquid) to spray into the nose. It is usually used every 10 to 12 hours as needed, but not more often than twice in a 24-hour period. Follow the directions on the package label or on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use oxymetazoline nasal spray exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor or directed on the label.

If you use oxymetazoline nasal spray for more often or for longer than the recommended period of time, your congestion may get worse or may improve but come back. Do not use oxymetazoline nasal spray for longer than 3 days. If your symptoms do not get better after 3 days of treatment, stop using oxymetazoline and call your doctor.

Oxymetazoline nasal spray is only for use in the nose. Do not swallow the medication.

To prevent the spread of infection, do not share your spray dispenser with anyone else. Rinse the tip of the dispenser with hot water or wipe it clean after you use it.

Follow the directions for using the nasal spray that appear on the package label. If you are using a product that comes in a pump dispenser, press down on the rim several times before using your first dose to prime the pump, according to the directions on the label. When you are ready to use the spray, hold your head upright without tilting and place the tip of the bottle in your nostril. For the nasal spray, squeeze the bottle quickly and firmly. For products that come in a pump dispenser, press down on the rim with a firm, even stroke and breathe in deeply.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before using oxymetazoline,

• tell your doctor and pharmacist if you are allergic to oxymetazoline, or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate).
• tell your doctor if you have or have ever had high blood pressure, diabetes, difficulty urinating due to an enlarged prostate gland, or thyroid or heart disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using oxymetazoline nasal spray, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

This medication is usually used as needed. If your doctor has told you to use oxymetazoline regularly, use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat, light, and moisture (not in the bathroom). Do not freeze the medication. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?

If you use too much oxymetazoline nasal spray or if someone swallows the medication, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911

What OTHER INFORMATION should I know?

Ask your pharmacist any questions you have about oxymetazoline nasal spray.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: November 15, 2012.